Summary: Guarantee the operation in compliance of all the pharmaceutical end general equipment and systems present in Saluggia site (intended GMP compliance, Normative and Standard compliance, eCompliance) in order to satisfy necessary requirements of pharmaceutical processes and safety requirements, with particular attention to the Aseptic Processes. About the Role: Major Accountabilities - Guarantee the correct operation of the equipment, systems, plants present in the production site through the coordination of all the Technical activities, carried out by external resources - Coordinate the technical activities on the equipment as improvement projects and upgrade projects on the same ones - Support the production activities participating in the multi-department workshops and projects - Guarantee the Aseptic process compliance (by equipment upgrade) and Aseptic Process improvement - Collaborate with MS&T and Production department to understand better their needs and processes for equipment compliance, efficiency, and reliability (evaluating needs for upgrade or substitution) - Accountability and/or responsibility for the GMP documentation both external and internal - Improvement of the qualification, validation and other GMP / technical documentation adapting it to the corporate standards - Execute qualification and validation activities or coordinate external resources in the execution under own accountability - Support the process of Continuous Improvement and Compliance for aseptic processes - Support eCompliance improvement projects - Guarantee the safety of internal and external resources working on the equipment, in accordance with applicable normative and corporate procedures (through the implementation of preventive measures). Key Performance Indicators Active collaboration in multi-department teams to guarantee: - Compliance of the production processes (by equipment and systems compliance) - Execution of the Production planning (by efficiency and reliability of the equipment) - GMP compliance and eCompliance of the equipment and systems (by respecting maintenance, calibration, and requalification plans) - Qualification and Validation of the new equipment or systems respecting scheduling and budget of the Investment projects - Execution of the Site Quality Plan Job Dimensions Subordinate Functions: None Number of Associates: Direct: 0; Indirect: 2-3 Financial responsibility (where appropriate): N/A Impact on the organisation (where appropriate): High. Efficiency and Reliability of the equipment as well as GMP Compliance and eCompliance is necessary pre-requirement to guarantee: - Product quality - Production planning - Quality Plan respect Ideal Background (State the minimum and desirable education and experience level) Education: Batchelor Degree In Engineering (5 years) - preferably electrical or mechanical Division Operations Business Unit Innovative Medicines Location Italy Site Saluggia Company / Legal Entity IT58 (FCRS = IT058) AAA Italy Srl. Functional Area Technical Operations Job Type Full time Employment Type Regular Shift Work No Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.